Human Drugs View

Product Information BR-1429_PI_01.pdf
Registration Number BR-1429
Generic Name Nonacog alfa
Brand Name BeneFIX
Dosage Strength 1000IU
Dosage Form Lyophilized Powder for Solution for Injection (IV)
Classification Prescription Drug (RX)
Pharmacologic Category Blood Coagulation Factors (Coagulation Factor IX)
Packaging Single use. One box contains: 10 mL Type I borosilicate glass vial with gray chlorobutyl rubber stopper and aluminum flip-off seal, 5 mL Type I borosilicate pre filled glass syringe with grey bromobutyl rubber plunger stopper and syringe closure (0.234% Sodium Chloride as diluent), vial adapter reconstitution device, infusion set, plaster, gauze pad, and two (2) alcohol swabs.
Manufacturer Wyeth Farma, S.A.
Country of Origin Spain
Trader N/A
Importer Pfizer, Inc.
Distributor Pfizer, Inc.
Application Type Monitored Release (MR)
Issuance Date 08 November 2022
Expiry Date 08 November 2027